How to Trial a Device in a VCH Facility
PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES How to Trial a Device in a VCH Facility Gordon McConnell, P. Eng. Vancouver Coastal Health Authority PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES R K MANAGEMENT RIS HR CREB VCHRI BME OPERATING ROOMS SSD INFECTION CONTROL PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES The Medical Device Development Safety Committee (Th Reprocessing (The R i Variance V i Committee) C itt ) Committee Risk Management (Medical Affairs) Infection Control Medical Device Reprocessing Department (MDRD) Biomedical Engineering Operating Rooms Diagnostic Imaging PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES YES Research? NO CREB VCHRI PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES CREB – Clinical Research Ethics Board VCHRI – Vancouver Coastal Health Research Institute All research studies involving human subjects that utilize VCH property, resources, facilities, patients or staff, must receive VCH approval to conduct research in addition to ethical approval approval. PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES GUIDELINE FOR OBTAINING APPROVAL TO CONDUCT RESEARCH AT VANCOUVER COASTAL HEALTH http://www.vchri.ca/ DEFINITION OF RESEARCH A research study … will be considered … as being research involving human subjects if: • A human is subjected to procedures, the purpose of which go beyond the subject’s need for prophylaxis, diagnosis or therapy; or • A human h iis subjected bj d to procedures d which hi h are experimental i lb but which hi h d do not necessarily go beyond the subject’s need for prophylaxis, diagnosis, or therapy; or • Procedures are used in which an invasion of privacy may be involved, for example, by examination of records, by interviews, by observations, by administration of a questionnaire or test, or by audio or video recording; or • Human tissue, biological fluids, embryos or fetuses are being studied. PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES GUIDANCE: WHEN DOES YOUR PROJECT WARRANT REVIEW BY A RESEARCH ETHICS BOARD? http://www.vchri.ca/ http://www vchri ca/ Does your project warrant review by a research ethics thi board? b d? 1. … 2. … 3 Does the project involve the use of a medical device … which 3. requires approval from Health Canada … 4. … PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES Examples of Non-Research Devices: Shuttle Reusable Blanket for a Forced-Air Patient Warmer PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES Shuttle Forced-Air Patient Warmer PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES YES Research? NO CREB VCHRI PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES HEALTH CANADA Food and Drugs Act Medical Device Regulations Is the item a medical device? If so, what h t is i its it class? l ? Does it have a medical device licence? Does the use of the device constitute a “sale”? PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES The Definition Th D fi iti off a M Medical di l D Device i under d th the Food F d and d Drugs Act The Food and Drugs Act (1) defines a "device" as any article, instrument, apparatus or contrivance, including any component, part of accessory thereof, manufactured, sold or represented for use in: the diagnosis, diagnosis treatment treatment, mitigation or prevention of a disease, disease disorder or abnormal physical state; restoring, correcting or modifying a body function or the body structure; the diagnosis of pregnancy; or care during pregnancy and at and after birth. PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES M di l D Medical Device i Cl Classification: ifi ti … Medical devices are classified into one of Classes I to IV by means of the classification rules … where Class I represents the lowest risk and Class IV represents the highest risk. … … no person shall import or sell a Class II, III or IV medical device unless the manufacturer of the device holds a licence in respect of that device … PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfbhtt // h /dh / lt f t /h fb dgpsa/pdf/md-im/keyword_motscles2-eng.pdf PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES Medical Device Licence http://www.hc http://www hc-sc sc.gc.ca/dhp gc ca/dhp-mps/md-im/licen/mdlicmps/md im/licen/mdlic eng.php PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES Medical Devices Regulations http://laws-lois.justice.gc.ca/eng/regulations/ … These Regulations apply to (a) the sale and advertising for sale of a medical device; and (b) the importation of a medical device for sale or for use on i di id l other individuals, th th than iimportation t ti ffor personall use. Therefore, if the medical device “belongs to” VCH and there is no o “sale” sa e o or “importation” po tat o involved o ed with t it, t, tthe e MDR do not ot apply. PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES Medical Devices Regulations ● PART 1 GENERAL Device has a medical device licence if Class 2, 3, or 4. ● PART 2 CUSTOM-MADE DEVICES AND MEDICAL DEVICES TO BE IMPORTED OR SOLD FOR SPECIAL ACCESS (1) This Part applies to custom-made devices and medical devices that are to be imported p or sold for special p access. (2) In this Part, “special access” means access to a medical device for emergency use or if conventional therapies have failed, are unavailable or are unsuitable ● PART 3 MEDICAL DEVICES FOR INVESTIGATIONAL TESTING INVOLVING HUMAN SUBJECTS This Part applies to medical devices that are to be imported or sold for investigational testing involving human subjects PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES Medical Device Regulations The medical device that I mentioned is … . The researchers have done substantial bench testing and would now like to test the device in parallel with the conventional means … to validate the technique and to gather data to help with the design of the device. The research proposal was submitted to the Clinical Research Ethics Board and given provisional approval pending contact with Health Canada regarding licensing. The principle investigator is an orthopedic surgeon on staff at Vancouver General Hospital, and the device is being developed in conjunction with a medical engineering professor and a graduate student at the University of British Columbia as a Master of Applied Science project. My question to you is whether the device requires a license given that it is custom built for use at VGH, and at this point, is being evaluated only for "proof of principle" which precedes any thought of commercialization (i.e., sale or distribution) of the product. PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES Medical Device Regulations … We have looked at the scenario below and if according to the definition of sell in the Food and Drugs Act, this product is not being sold or distributed to a party outside of the hospital then the product would not need to have a medical device licence. If however you wish to distribute to other hospitals, then you would need to obtain a medical device licence for the product. Sincerely, Nancy Shadeed Head, Regulatory and Scientific Section Device Licensing Division Medical Devices Bureau PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES YES Research? NO CREB VCHRI Biomedical Engineering and Medical Device Reprocessing Committee PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES Process Flow Chart (Beadon Protocol) Dose Mapping Start Maximum Dose Determination Minimum Dose Determination Permission from the OR Mechanical Safety Tests Electrical Safety Tests Proposed Sterilization Method Sterilization Validation MDDSC Biomedical Engineering and Reprocessing Variance Committee Additional D i andd Design Function Information CREB Application MDDSC Variance Committee Biomedical Engineering and Reprocessing Approval to Proceed Approval Application for VCHRI Approval PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES Electrical Testing The VCHA Biomedical Engineering Department assures the device has the necessary approvals evaluates the device to assure it is safe to use in the proposed research inspects the device using in-house inspection procedures Inspection Procedure: General Device Vancouver Coastal Health Authority Biomedical Engineering Department G25 PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES M h i lT Mechanical Testing ti The VCHA Biomedical Engineering Department evaluates the device to assure it is safe to use in the proposed research assures that the device remains intact and functional after exposure to the environment and the stresses that it will experience throughout sterilization and use cycles. PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES Sterilization Method See “Guidance concerning sterilization instructions for research devices for use on humans” at http://vchconnect.vch.ca/programs_services/client_relations/reprocessing_of_medical_devices/reprocessin g_variance_cmtee/page_78970.htm The necessaryy level of sterilization ((or disinfection)) is determined (Spaulding’s Classification of Medical Equipment and Required Level of Processing). The method of sterilization is chosen ((MoH Guidelines for the Cleaning Disinfection and Sterilization of Medical Devices in Health Authorities). Ap plan for the validation of the sterilization method is chosen. The validation tests are minimum dose determination, maximum dose determination and, when radiation is used, dose mapping. p g Variance Committee may y require q a sterilization The Reprocessing challenge. PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES Mi i Minimum D Dose D Determination i i The minimum sterilization dose necessary to ensure sterility must be determined. A sterilization facility will sterilize samples at different doses. These Th sterilized t ili d samples l sentt tto a microbiology i bi l lab for sterility testing. PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES D Dose M Mapping i Devices that will be sterilized using irradiation techniques must undergo a dose-mapping procedure. Dose mapping is the determination of the zones of minimum i i and d maximum i d dose iin th the d device i package k b by placing dosimeters at strategic locations. This p process allows for the dose being g applied pp at various areas of the device to be correlated to the dose measured at a position outside the device packaging. This is necessary to ensure that the minimum dose is applied to the entire device. PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES M i Maximum D Dose D Determination i i Testing is done to assure the function of the device is not compromised when the device is sterilized. The Th function f ti and d safety f t off a single-use i l d i iis device verified after sterilization with a dose that is greater than what would normally be used. Re-usable devices are tested after being subjected to a dose in excess of the total dose that can be applied to the device based on the number of reprocessing cycles allowed. allowed PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES S ili i Ch Sterilization Challenge ll A sterilization challenge test may be needed if the device is likelyy to be difficult to sterilize. The sterilization challenge involves inoculating the device with a known concentration of organisms, processing it with the prescribed cleaning and sterilization technique technique, and then performing the aforementioned sterility tests. PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES Use of Non-Medical Devices in Patient Care Areas and the Patient Care Environment CSA Z32: Electrical safety and essential electrical systems in health care facilities Patient Care Area: An area intended primarily for diagnosis, therapy, or care. Patient Care Environment: A Zone … that has been preselected for the accommodation of a patient bed … and … equipment involved in patient treatment … which includes space within the room 1.5 m beyond the perimeter of the bed … and to within 2 2.3 3 m of the floor floor. PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES Use of Non-Medical Devices in Patient Care A Areas and d th the P Patient ti t C Care E Environment i t CSA Z32: Electrical safety and essential electrical systems in health care facilities 4.3.4 Non –medial electrical equipment used in patient care areas 4.3.4.1 General The HCF’s Th HCF’ nonmedical di l electrical l t i l equipment i t shall h ll be b approved d … to t the th applicable Standard and shall be covered by the HCF’s electrical safety program. 4.3.4.2 Patient environment requirements … non-medical electrical equipment to be used in the patient care environment shall (a)be battery powered and less than 30 V; (b)be limited to extra-low-voltage extra low voltage Class 2 circuits; or (c)have a leakage current, chassis to ground, of less that 500 µA PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES Use of Non-Medical Devices in Patient Care Areas and the Patient Care Environment CAN/CSA-C22.2 NO. 60601-1-1-02 (R06) - Medical Electrical Equipment - Part 11: General Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems Annex I (informative) ME system aspects I.1 Combinations of ME Equipment and non-ME Equipment I.1.1 … This annex provides a summary of situations that could occur when different combinations of equipment are used in various medical environments. … I.1.2 Localities in a medical environment The following localities are foreseen The p patient environment as p part of a medically y used room A medically used room, excluding the patient environment The non-medically used room … PROCESS FOR INVESTIGATIONAL MEDICAL DEVICES Acknowledgements Katherine Beadon, B.Sc. (Physics), MASc g g UBC Mechanical Engineering Antony Hodgson, PhD, PEng Professor & NSERC Chair in Design Engineering UBC Mechanical Engineering Biomedical o ed ca Engineering g ee g [email protected]
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